CSL Behring’s Afstyla, a new preventative treatment for hemophilia A developed in Korea, has obtained a license from the Korean Ministry of Food and Drug Safety. The Ministry approved the drug for treating children and adults with hemophilia A.
What is Afstyla?
Afstyla is a novel single-chain recombinant antihemophilic factor VIII approved by the U.S. Food and Drug Administration (FDA) to treat patients with hemophilia A, an inherited bleeding disorder that prevents the blood from clotting normally due to the lack of a protein called factor VIII. The drug is produced in Chinese hamster ovary cells as a single-chain polypeptide. It has increased stability in circulation and provides long-lasting protection from bleeds with twice-weekly dosing. Afstyla is identical natural factor VIII.
The treatment is used for the prevention and suppression of hemorrhage, routine prevention of bleeding or reduction of bleeding frequency, and prevention before and after surgery. It is not used to treat patients with Von Willebrand Disease, reports Korea Biomedical News.
According to the company, Afstyla is the first and only single-chain treatment for hemophilia A, specifically developed for long-term bleeding control with two-or three-times injections a week. When activated in the body, reports Korea Biomedical News, it shows the same effect as blood clotting Factor III.
The AFFINITY Studies
The Korean approval was based on the results of the AFFINITY studies, including two clinical trials on pediatric, adolescent, and adult patients with hemophilia A, and one open-label, multi-center study that extended the existing trial. The results of the studies showed that once patients were treated with Afstyla had zero annualized spontaneous bleeding rate (AsBR) on average, reported Korean Biomedical Review. For a list of AFFINITY Clinical Investigators, see the link.Source: Korea Biomedical Review